FDA 510(k) Application Details - K203661

Device Classification Name	Refrigerant, Topical (Vapocoolant)   More FDA Info for this Device
510(K) Number	K203661
Device Name	Refrigerant, Topical (Vapocoolant)
Applicant	CryoScience North America, Inc. 401 Louisuana St, 8th Floor Houston, TX 77002-1629 US Other 510(k) Applications for this Company
Contact	Greg Nehrlich Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2020
Decision Date	05/25/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review